Safety Study of LLF580 in Obese Volunteers
A 12 Week Phase Ib Randomized Investigator and Subject Blinded Placebo Controlled Repeat-dose Study of LLF580
1 other identifier
interventional
61
1 country
7
Brief Summary
The purpose of the study is to evaluate the safety and tolerability of multiple doses of LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study will also determine early efficacy signals in various metabolic diseases associated with elevated triglycerides and/or obesity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 obesity
Started Feb 2018
Typical duration for phase_1 obesity
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2018
CompletedStudy Start
First participant enrolled
February 26, 2018
CompletedFirst Posted
Study publicly available on registry
March 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2019
CompletedOctober 12, 2021
October 1, 2021
1.7 years
February 9, 2018
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability following repeated dosing of LLF580
To assess the safety and tolerability in obese subjects following repeated dosing of LLF580 by subcutaneous (SC) injection over 12 weeks.
12 weeks
Secondary Outcomes (8)
LDL-C, HDL-C
12 weeks
serum CTX-1, P1NP, and osteocalcin
12 weeks
Body weight
12 weeks
BMI
12 weeks
serum BSAP
12 weeks
- +3 more secondary outcomes
Study Arms (2)
LLF580
EXPERIMENTALLLF580 every 28 days \* 3
Placebo
PLACEBO COMPARATORPlacebo to LLF580 every 28 days \* 3
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) within the range of 30 to 45 kg/m2, inclusive, with ethnic adjustment (≥27.5 kg/m2 for Asian individuals).
- Fasting triglyceride 150 - 500 mg/dL (1.69 - 5.65 mmol/L), inclusive, at screening.
- Able to communicate well with the investigator, to understand and comply with the requirements of the study.
You may not qualify if:
- History of hepatobilliary disease.
- Liver disease or liver injury as indicated by abnormal liver function tests.
- Chronic infection with Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or Hepatitis C (HCV).
- Fasting triglycerides greater than or equal to 500 mg/dL \[5.65 mmol/L\], or concomitant use of drug treatment for hypertriglyceridemia (fibrates, omega-3 fatty acids, nicotinic acid).
- History of pancreatic injury or pancreatitis.
- History of hypersensitivity to drugs of similar biological class, FGF21 protein analogue, or Fc fusion proteins.
- History of bone disorders or low vitamin D level.
- Contraindications to MRI.
- Change in body weight (more than 5% self-reported OR 5 kg self-reported change during the previous 3 months).
- Use of weight loss drugs.
- Enrollment in a diet, weight loss or exercise programs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Novartis Investigative Site
Jacksonville, Florida, 32216, United States
Novartis Investigative Site
Miami, Florida, 33126, United States
Novartis Investigative Site
Overland Park, Kansas, 66212, United States
Novartis Investigative Site
Lincoln, Nebraska, 68502, United States
Novartis Investigative Site
High Point, North Carolina, 27265, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104, United States
Novartis Investigative Site
Knoxville, Tennessee, 37920, United States
Related Publications (1)
Rader DJ, Maratos-Flier E, Nguyen A, Hom D, Ferriere M, Li Y, Kompa J, Martic M, Hinder M, Basson CT, Yowe D, Diener J, Goldfine AB; CLLF580X2102 Study Team. LLF580, an FGF21 Analog, Reduces Triglycerides and Hepatic Fat in Obese Adults With Modest Hypertriglyceridemia. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e57-e70. doi: 10.1210/clinem/dgab624.
PMID: 34431493DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2018
First Posted
March 15, 2018
Study Start
February 26, 2018
Primary Completion
November 13, 2019
Study Completion
November 13, 2019
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com